Device manufacturer, as written on reports

Abbott Diagnostics Scarborough: medical device reports filed with FDA

12,943 reports name it as the manufacturer of the device involved, 2019–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

12,943
reports naming it as manufacturer: 0.1% of all MAUDE reports; 718
reports, 12 months to August 2026: 481 in the 12 months before; 96.5%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

12,943 medical device reports received by FDA give Abbott Diagnostics Scarborough as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 2019 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

718 reports arrived in the 12 months to August 2026, up 49% from 481 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.5%), injury (3.5%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Id Now Covid-19 Assay	Reagents, 2019-novel coronavirus nucleic acid	3,357	0	0%
Binaxnow Covid-19 Ag Card	Coronavirus antigen detection test system.	2,048	0	0%
Binaxnow Covid-19 Ag Self Test 2ct	Coronavirus antigen detection test system.	1,297	53	0.1%
Id Now Covid-19	Reagents, 2019-novel coronavirus nucleic acid	865	0	0.4%
DETERMINE HIV-1/2 Ag/Ab COMBO 25T	Test, hiv detection	801	569	0%
ID NOW COVID-19 2.0 Test KIT 24T JAPAN	Reagents, 2019-novel coronavirus nucleic acid	704	37	0%
Binaxnow Covid-19 Antigen Self Test	Coronavirus antigen detection test system.	595	0	0%
Id Now Covid 19 Assay	Reagents, 2019-novel coronavirus nucleic acid	523	0	0%
Id Now Covid-19 2 0 Test Kit 24t Ous	Reagents, 2019-novel coronavirus nucleic acid	489	0	0%
Binaxnow Covid-19 Antigen Self-Test	Coronavirus antigen detection test system.	461	0	0%
Binax Now Covid-19 Ag Card	Coronavirus antigen detection test system.	421	0	0%
Id Now Covid-19 2 0 Test Kit 24t Eua	Reagents, 2019-novel coronavirus nucleic acid	158	12	0%
Alere Determine Hiv-1/2 Ag/Ab Combo	Test, hiv detection	63	0	0%
Alere Determine Hiv 1/2 Ag/Ab Combo	Test, hiv detection	6	0	0.2%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
QJR	Reagents, 2019-novel coronavirus nucleic acid	6,233	48.2%
QKP	Coronavirus antigen detection test system.	5,437	42%
MZF	Test, hiv detection	997	7.7%
OOI	Real time nucleic acid amplification system	45	0.3%
OCC	Respiratory virus panel nucleic acid assay system	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.1%7

Injury3.5%450

Malfunction96.5%12,484

Other0%0

Not given0%2

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Abbott Diagnostics Scarborough reports

How many FDA device reports name Abbott Diagnostics Scarborough as manufacturer?

12,943 reports through August 2026, 718 of them in the latest 12 months.

Which of its brands appear most often?

Id Now Covid-19 Assay (3,357), Binaxnow Covid-19 Ag Card (2,048), Binaxnow Covid-19 Ag Self Test 2ct (1,297), Id Now Covid-19 (865) and DETERMINE HIV-1/2 Ag/Ab COMBO 25T (801).

Which device types does it report on?

reagents, 2019-novel coronavirus nucleic acid (48.2%), coronavirus antigen detection test system. (42%), test, hiv detection (7.7%) and real time nucleic acid amplification system (0.3%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.